Gastric Cancer, Peritoneal Metastases
Conditions
Brief summary
Patients with stage cT3-4N+M0 gastric cancer were recommended to receive neoadjuvant chemotherapy before radical surgery in terms of the eradication of micrometastasis in addition to local control, higher compliance with intensive chemotherapy, and avoidance of futile surgery by detection of initially invisible distant metastasis after rapid disease progression. However, in some studies, gastrectomy followed by neoadjuvant chemotherapy failed to demonstrate survival benefits for these patients. And peritoneal recurrence was the most common and devastating reason. Hyperthermic intraperitoneal chemotherapy (HIPEC) was introduced for peritoneal cancer last century. A few studies suggested HIPEC could improve prognosis in patients with limited peritoneal metastasis from various cancer. In summary, we conducted this study to confirm the efficacy and safety of HIPEC after gastrectomy in patients with advanced gastric cancer received neoadjuvant chemotherapy.
Interventions
COMBINATION_PRODUCTHIPEC
HIPEC after gastrectomy with D2 local lymph node dissection.
Sponsors
Zhixin Cao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* histologically proven adenocarcinoma of stomach * stage cT3-4N+M0 * no involvement of esophagus \> 3 cm * ECOG (Eastern Cooperative Oncology Group) : 0\ 1 * no previous chemotherapy or radiotherapy for any malignancy * no previous surgery for GC excluding endoscopic mucosal resection or endoscopic submucosal dissection * Signed the Informed Consent Form
Exclusion criteria
* Serious diseases that are difficult to control * Severe hepatic and renal dysfunction * Abnormal coagulation * The presence of other serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study, or interfere with the results of the study, as well as the patients who the investigator believes are not suitable for participating in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peritoneal recurrence | 3 years | — |
| OS | 3 years | overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DFS | 3 years | disease free survival |
| Adverse Events | 3 years | Number and degree of Adverse Events |
Outcome results
None listed